Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses
United Kingdom73 participantsStarted 2024-08-01
Plain-language summary
The purpose of the study is to compare clinical performance between two soft contact lenses.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
i. Age 8 to 18 years; at least half the population will be children or adolescents aged 8 to 15 years.
ii. Have experience with soft contact lens wear and able to insert and remove soft contact lenses.
iii. Parent/guardian and participant have read and understood the Participant Information Sheet.
iv. Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable).
v. Best corrected visual acuity of at least 20/25 in each eye.
vi. Have normal eyes with the exception of the need for visual correction.
vii. Spectacle refraction:
* Age 8 to 12: -0.75D to -4.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of \<1.00D
* Age 13-18: -0.75D to -7.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of \<1.00D.
viii. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.
Exclusion Criteria:
i. Acute and subacute inflammation or infection of the anterior chamber of the eye.
ii. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
iii. Severe insufficiency of lacrimal secretion (dry eyes).
iv. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
v. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
vi. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lense…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Absolute Decentration
Timeframe: At the end of one week daily disposable wear, after at least three hours of wear.
2
Contact Lens Centration
Timeframe: At the end of one week daily disposable wear, after at least three hours of wear.
3
Contact Lens Movement
Timeframe: At the end of one week daily disposable wear, after at least three hours of wear.